Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Unit, X-Ray, Intraoral
510(k) Number K896963
Device Name TRIMODE SP DENTAL INTRA ORAL X-RAY
Applicant
Tempo Technology, Inc.
Rte. 1, Dowell Rd.
Columbia City,  IN  46725
Applicant Contact CHRISTOPHER E DARE
Correspondent
Tempo Technology, Inc.
Rte. 1, Dowell Rd.
Columbia City,  IN  46725
Correspondent Contact CHRISTOPHER E DARE
Regulation Number872.1810
Classification Product Code
EAP  
Date Received12/15/1989
Decision Date 01/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-